CIVCO General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments Inc is recalling 9 CIVCO General Purpose Sensor kits due to incorrect calibration that may affect needle path projection accuracy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential variability in needle path projection, which is a functional defect rather than a direct physical injury or contamination, fitting the criteria for moderate severity.
Plain-English summary
Civco Medical Instruments Inc is recalling 9 kits of the CIVCO General Purpose Sensor, a non-sterile reusable electromagnetic sensor used with 3D Guidance medSAFE trackers. The product, reference number 610-1067, is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
The recall was initiated because the sensors were incorrectly calibrated. This defect causes potential variability in the projected position of the needle path when used with the ultrasound device. The affected lot number is M713910.
The 9 kits were distributed worldwide, including in the United States (Wisconsin, California, Massachusetts, Indiana, Washington, and New Jersey) and foreign countries such as Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France. Users should stop using the affected sensors and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose s
- Manufacturer
- Civco Medical Instruments Inc
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number M713910
Distribution
Part of a larger recall action
This product is one of 5 recalled by Civco Medical Instruments Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Civco Medical Instruments Inc
See all →- HighCivco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks
FDA (Devices) · 2015-04-15
- ModerateCivco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak
FDA (Devices) · 2014-09-03
- ModerateCivco Belly Board Recalled Due to Misaligned Scales
FDA (Devices) · 2014-01-29
- ModerateCivco Belly Board MRI Recalled Due to Misaligned Scales
FDA (Devices) · 2014-01-29
- HighCivco VirtuTRAX Electromagnetic Sensor Recall Due to Calibration Error
FDA (Devices) · 2012-07-18
Same hazard · calibration error
See all →- ModeratePhotera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 3-D phototherapy device UV sensor calibration error recall
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 Phototherapy Device UV Sensor Calibration Error
FDA (Devices) · 2026-07-22
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11